MAUDE Adverse Event Report: PENTAX MEDICAL - A DIVISION OF PENTAX OF AMERICA, INC. PENTAX FIBEROPTIC GLIDESCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Catalog Number FB-15BS

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

The anesthesia team was attempting to intubate the patient using the glidescope.Staff noticed that there was rubber that peeled off into the tube.The glidescope was then switched out with one that was not defective.No injury to patient, but could have caused harm if it had not been noticed.

• Brand Name: PENTAX FIBEROPTIC GLIDESCOPE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): PENTAX MEDICAL - A DIVISION OF PENTAX OF AMERICA, INC.; 3 paragon drive; montvale NJ 07645
• MDR Report Key: 5142066
• MDR Text Key: 27988786
• Report Number: 5142066
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: FB-15BS
• Other Device ID Number: RMA#10087556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 43 YR
• Patient Weight: 97